A Study to Evaluate the Efficacy and Safety of ABC008 for Inclusion Body Myositis

Last updated: January 28, 2026
Sponsor: Abcuro, Inc.
Overall Status: Completed

Phase

2/3

Condition

Polymyositis (Inflammatory Muscle Disease)

Dermatomyositis (Connective Tissue Disease)

Idiopathic Inflammatory Myopathies

Treatment

ABC008

Clinical Study ID

NCT05721573
ABC008-IBM-201
  • Ages > 40
  • All Genders

Study Summary

A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Efficacy and Safety of ABC008 in the Treatment of Subjects with Inclusion Body Myositis

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult males and females age >40 years at the time of the first dose of studymedication;

  • Weight >40 and <150 kg;

  • Diagnosis of either clinico-pathologically defined IBM, clinically defined IBM, orprobable IBM according to the European Neuromuscular Centre (ENMC) IBM 2011 researchdiagnostic criteria (Rose et al., 2013). Documented histopathology results must beavailable prior to Baseline (Day 1) to confirm eligibility;

  • Able to arise from a chair (with armrests), with use of their arms but withoutsupport from another person or device (e.g., cane, walking stick), at Screening andBaseline (Day 1);

  • Able to walk 3 meters, turn around, walk back to the chair, and sit down, with orwithout assistive device. Once arisen from the chair, subject may use any walkingdevice but cannot be supported by another person, furniture, or a wall;

Exclusion

Exclusion Criteria:

  • Any other form of myositis or myopathy other than IBM, e.g., metabolic ordrug-induced myopathy, drug-induced myositis, anti-synthetase syndrome, polymyositisor dermatomyositis, cancer-associated myositis (myositis diagnosed within 3 years,either before or after), myositis in overlap with another autoimmune disease (e.g.,systemic lupus, systemic sclerosis, rheumatoid arthritis), or muscular dystrophy;

  • Any condition, e.g., severe degenerative arthritis with limited range of motion,which precludes the ability to quantitate muscle strength or perform functionalassessments (e.g., mTUG), in the Investigator's opinion;.

  • Presence of another autoimmune or autoinflammatory disease other than indicationunder study, e.g., rheumatoid arthritis, psoriatic arthritis, axialspondyloarthropathy, inflammatory bowel disease, systemic lupus erythematosus.Subjects with Sjogren's syndrome, T-cell large granular lymphocyte leukemia (T-LGLL), or well-controlled thyroid disease are permitted;

Study Design

Total Participants: 272
Treatment Group(s): 1
Primary Treatment: ABC008
Phase: 2/3
Study Start date:
February 28, 2023
Estimated Completion Date:
November 27, 2025

Study Description

A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Efficacy and Safety of ABC008 in the Treatment of Subjects with Inclusion Body Myositis Detailed Description: A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Efficacy and Safety of ABC008 in the Treatment of Subjects with Inclusion Body Myositis Detailed Description: This is a Phase II/III randomized, double-blind, placebo-controlled, parallel multicenter study with 3 parts.

The study will include a sentinel cohort (Part A) of 30 subjects who will receive first three doses of the study drug. Safety data from subjects in the sentinel cohorts will be evaluated by a Data and Safety Monitoring Board (DSMB) before further dosing of the sentinel cohort, as well as initiation of enrollment in the double-blind safety and efficacy cohort (Part B). After completion of Part A or Part B, subjects have the option of enrolling in an open-label long-term extension study or progressing to the pharmacodynamics (PD) recovery cohort (Part C), to evaluate the recovery of the depletion of killer cell lectin-like receptor G1 (KLRG1)+ cells after the end of treatment with ABC008.

Efficacy, safety, HRQoL, and HRU assessments will be conducted. Blood samples will be obtained to evaluate the serum PK, PD, and immunogenicity of ABC008 throughout the study.

Connect with a study center

  • Royal North Shore Hospital

    Saint Leonards, New South Wales 2155400 2065
    Australia

    Site Not Available

  • Royal Brisbane and Women's Hospital

    Herston, Queensland 4006
    Australia

    Site Not Available

  • Royal Brisbane and Women's Hospital

    Herston 6931014, Queensland 2152274 4006
    Australia

    Site Not Available

  • Perron Institute for Neurological and Translational Science

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Perron Institute for Neurological and Translational Science

    Nedlands 2064874, Western Australia 2058645 6009
    Australia

    Site Not Available

  • AZ Sint-Lucas & Volkskliniek

    Gent, 9000
    Belgium

    Site Not Available

  • AZ Sint-Lucas & Volkskliniek

    Ghent 2797656, 9000
    Belgium

    Site Not Available

  • Heritage Medical Research Clinic - University of Calgary

    Calgary, Alberta 3M 1M4
    Canada

    Site Not Available

  • Heritage Medical Research Clinic - University of Calgary

    Calgary 5913490, Alberta 5883102 3M 1M4
    Canada

    Site Not Available

  • Genge Partners Inc.

    Montréal, Quebec H4A 3T2
    Canada

    Site Not Available

  • Genge Partners Inc.

    Montreal 6077243, Quebec 6115047 H4A 3T2
    Canada

    Site Not Available

  • Hospital Pitie-Salpetriere - AP-HP

    Paris, 75013
    France

    Site Not Available

  • Hospital Pitie-Salpetriere - AP-HP

    Paris 2988507, 75013
    France

    Site Not Available

  • Krankenhaus und Poliklinik Rüdersdorf GmbH

    Berlin, 15562
    Germany

    Site Not Available

  • Krankenhaus und Poliklinik Rüdersdorf GmbH

    Berlin 2950159, 15562
    Germany

    Site Not Available

  • University Hosptial Duesseldorf

    Düsseldorf, 40225
    Germany

    Site Not Available

  • University Hosptial Duesseldorf

    Düsseldorf 2934246, 40225
    Germany

    Site Not Available

  • University College London Hospitals NHS Foundation Trust, National Hospital for Neurology and Neurosurgery (NHNN)

    London, WC1N 3BG
    United Kingdom

    Site Not Available

  • University College London Hospitals NHS Foundation Trust, National Hospital for Neurology and Neurosurgery (NHNN)

    London 2643743, WC1N 3BG
    United Kingdom

    Site Not Available

  • Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust

    Salford, M6 8HD
    United Kingdom

    Site Not Available

  • Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust

    Salford 2638671, M6 8HD
    United Kingdom

    Site Not Available

  • Neuromuscular Research Center

    Phoenix, Arizona 85028
    United States

    Site Not Available

  • Neuromuscular Research Center

    Phoenix 5308655, Arizona 5551752 85028
    United States

    Site Not Available

  • University of California Irvine Medical Center (UCIMC) - Amyotrophic Lateral Sclerosis (ALS) and Neuromuscular Center

    Irvine, California 92868
    United States

    Site Not Available

  • Keck Hosptial of USC

    Los Angeles, California 90033
    United States

    Site Not Available

  • UCLA Medical Center

    Los Angeles, California 90095
    United States

    Site Not Available

  • Stanford Neuroscience Medical Center

    Palo Alto, California 94304
    United States

    Site Not Available

  • University of California, San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • University of California Irvine Medical Center (UCIMC) - Amyotrophic Lateral Sclerosis (ALS) and Neuromuscular Center

    Irvine 5359777, California 5332921 92868
    United States

    Site Not Available

  • Keck Hosptial of USC

    Los Angeles 5368361, California 5332921 90033
    United States

    Site Not Available

  • UCLA Medical Center

    Los Angeles 5368361, California 5332921 90095
    United States

    Site Not Available

  • Stanford Neuroscience Medical Center

    Palo Alto 5380748, California 5332921 94304
    United States

    Site Not Available

  • University of California, San Francisco

    San Francisco 5391959, California 5332921 94143
    United States

    Site Not Available

  • University of Colorado Hospital Anschutz Outpatient Pavillion

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University of Colorado Hospital Anschutz Outpatient Pavillion

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

  • Yale School of Medicine

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • Yale School of Medicine

    New Haven 4839366, Connecticut 4831725 06519
    United States

    Site Not Available

  • Mayo Clinic

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Mayo Clinic

    Jacksonville 4160021, Florida 4155751 32224
    United States

    Site Not Available

  • Northwestern Memorial Hospital, Department of Neurology (Clinic)

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Northwestern Memorial Hospital, Department of Neurology (Clinic)

    Chicago 4887398, Illinois 4896861 60611
    United States

    Site Not Available

  • University of Kansas Medical

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • University of Kansas Medical

    Kansas City 4273837, Kansas 4273857 66160
    United States

    Site Not Available

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland 21224
    United States

    Site Not Available

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Johns Hopkins Bayview Medical Center

    Baltimore 4347778, Maryland 4361885 21224
    United States

    Site Not Available

  • Johns Hopkins University School of Medicine

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Site Not Available

  • Brigham and Womens Hospital

    Boston, Massachusetts 021158
    United States

    Site Not Available

  • Neuromuscular Diagnostic Center - Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Brigham and Womens Hospital

    Boston 4930956, Massachusetts 6254926 021158
    United States

    Site Not Available

  • Neuromuscular Diagnostic Center - Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Mayo Clinic

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • University of Nebraska Medical Center

    Omaha, Nebraska 98198
    United States

    Site Not Available

  • University of Nebraska Medical Center

    Omaha 5074472, Nebraska 5073708 98198
    United States

    Site Not Available

  • Columbia University Medical Center / The Neurological Institute of New York

    New York, New York 10032
    United States

    Site Not Available

  • Hospital for Special Surgery

    New York, New York 10021
    United States

    Site Not Available

  • Hospital for Special Surgery

    New York City, New York 10021
    United States

    Site Not Available

  • Columbia University Medical Center / The Neurological Institute of New York

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • Hospital for Special Surgery

    New York 5128581, New York 5128638 10021
    United States

    Site Not Available

  • Duke Neurological Disorders Clinic -1L

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Wake Forrest School of Medicine

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Duke Neurological Disorders Clinic -1L

    Durham 4464368, North Carolina 4482348 27710
    United States

    Site Not Available

  • Wake Forrest School of Medicine

    Winston-Salem 4499612, North Carolina 4482348 27157
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Site Not Available

  • The Ohio State University Wexner Medical Center

    Columbus 4509177, Ohio 5165418 43210
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland 5746545, Oregon 5744337 97239
    United States

    Site Not Available

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • UPMC Arthritis and Autoimmunity Center, Falk Clinic

    Pittsburg, Pennsylvania 15213
    United States

    Site Not Available

  • UPMC Arthritis and Autoimmunity Center, Falk Clinic

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Penn State Health Milton S. Hershey Medical Center

    Hershey 5193342, Pennsylvania 6254927 17033
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • UPMC Arthritis and Autoimmunity Center, Falk Clinic

    Pittsburgh 5206379, Pennsylvania 6254927 15213
    United States

    Site Not Available

  • Austin Neuromuscular Center

    Austin, Texas 78759
    United States

    Site Not Available

  • Texas Neurology

    Dallas, Texas 75206
    United States

    Site Not Available

  • Nerve and Muscle Center of Texas

    Houston, Texas 77030
    United States

    Site Not Available

  • Austin Neuromuscular Center

    Austin 4671654, Texas 4736286 78759
    United States

    Site Not Available

  • Texas Neurology

    Dallas 4684888, Texas 4736286 75206
    United States

    Site Not Available

  • Nerve and Muscle Center of Texas

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Virginia Commonwealth University

    Henrico, Virginia 23233
    United States

    Site Not Available

  • Virginia Commonwealth University

    Henrico 4763729, Virginia 6254928 23233
    United States

    Site Not Available

  • University of Washington Medical Center - Montlake

    Seattle, Washington 98195
    United States

    Site Not Available

  • University of Washington Medical Center - Montlake

    Seattle 5809844, Washington 5815135 98195
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Site Not Available

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